Swiss LithoClast Trilogy
FDA 510(k) K191124 · E.M.S Electro Medical Systems S.A
510(k) numberK191124
Submission
- Device name
- Swiss LithoClast Trilogy
- Applicant
- E.M.S Electro Medical Systems S.A
Nyon, CH - Received
- April 29, 2019
- Decision date
- May 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
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| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneELC · Traditional | 10/20/2019SE |
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| K182490 | Swiss LithoClast TrilogyFEO · Special | 10/09/2018SE |
| K181997 | Swiss LithoClast TrilogyFEO · Special | 08/30/2018SE |
| K181364 | Swiss LithoClast TrilogyFEO · Special | 06/20/2018SE |
| K173234 | Swiss LithoClast TrilogyFEO · Traditional | 01/10/2018SE |
Questions and answers
When was Swiss LithoClast Trilogy cleared by the FDA?
Swiss LithoClast Trilogy (K191124) received a 510(k) decision of Substantially Equivalent on May 29, 2019, 30 days after the submission was received.
What is the product code of K191124?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.